Connecting the DotsThe Criterion Edge Blog

View Criterion Edge’s President, Laurie Mitchell, and Evidence Partners’ President, Peter O’Blenis, for an xTalks webinar on State of the Art Literature Review: How To Get It Right. (recorded: December 11, 2018, 9 AM PST/12pm EST)
Tune in to learn about key components of an effective state of the art description as well as common points of failure in state of the art literature reviews. Peter and Laurie will expand on sound methods and expert tips for completing an effective literature search. They will be covering the best practices to efficiently produce and maintain a fully compliant and audit-ready clinical background/state of the art description using DistillerSR, and addressing any questions or concerns that may arise.

Kyoko brings over 30 years of expertise to share with clinical field scientists and managers, drug safety specialists, medical monitors, and more. Join Kyoko and other senior professionals during the webinar to learn more about familiarization and guidance using endpoint adjudication by the CEC. (more…)

There is no doubt that establishing state of the art is a challenge. It ranges from key information on the medical condition to a neutral, comprehensive analysis of treatment options, and culminates in a succinct yet comprehensive presentation that defines the currently accepted safety and performance standards against which the device is measured. Not surprisingly, common pitfalls include a perspective that is too broad and inclusion of too much detail, or a perspective that is too narrow, omitting relevant indications and alternative therapeutic options. An important critical aspect of the clinical evaluation that relies on state of the art data is also to appropriately define the position of the device within the currently available treatment portfolio.

The large number of mentions of state of the art throughout MEDDEV 2.7/1 rev 4 provide not only a comprehensive description of the importance, purpose, and role of establishing the state of the art, but also inform on how to incorporate this analysis into the clinical evaluation. The image below summarizes several core roles of this analysis.

Prior to MEDDEV 2.7/1 rev 4, guidance referred to state of the art only vaguely. MEDDEV 2.7/1 rev 3 requested the discussion of clinical data “in comparison with” and “taking account of” state of the art, and that the clinical literature data cited “reflect current medical practice and the generally acknowledged state of the art technologies”. From a methodological standpoint, this is not much guidance. Thus, methodology, depth, and presentation of the medical background for a device was largely left to one’s interpretation, and thus conducted inconsistently, or, at least, heterogeneously. (more…)

About the Blog

In this blog, we share our insights and experiences to help companies build quality, scalability, and flexibility into their regulatory writing. We hope you find it insightful. For questions, please contact info@criterionedge.com.